The Phase 1 clinical trial conducted on 90 healthy volunteers is underway with trial completion expected in March 2016. Three different concentrations of PHMB and placebo eye-drops are being tested to determine whether PHMB is safe, and what is the highest tolerable dose in healthy volunteers. This phase I trial, which started in September 2015, is held at three clinical centres in the Netherlands and Belgium. Volunteers are screened (to ensure that they meet all the criteria for the trial) and will use the study medication (PHMB or placebo eye drops) during two weeks. They will visit the clinical centre several times in order to check whether the eye drops have any effect on their eyes or on routine blood tests. The subjects will also be asked to report any possible side effects of the eye drops.
Once the phase I trial has been completed successfully, a larger phase III study in patients will follow.
Patient Recruitment for Phase III Clinical Trials
Dealing with a rare infectious disease such as Acanthamoeba Keratitis (AK) creates a particular patient recruitment challenge. ODAK trials will require patients to be identified in the early stages of the disease and rapidly recruited. To achieve this, the project is reliant upon optometrists and ophthalmologists referring patients. Eligible patients will be diagnosed with Acanthamoeba keratitis if they meet the following criteria:
- Culture positive and or histology positive
- In case of negative microbiologic culture or biopsy not performed, patients with history of contact lens wearing supported by specific clinical findings suggestive of Acanthamoeba keratitis such as presence of perineural infiltrates and/or ring infiltrates and/or keratitis with/or without disproportionate pain
Patients to be excluded from clinical trial
- Acanthamoeba keratitis diagnosis made “late” (later than 2 months)
- Patients with immunodeficiency disease
- Presence of concomitant infection due to virus or fungi
- Patients treated with other cysticidal drug prior to study entry.
When the infection is confirmed in new patients they will be made aware of the study and asked to participate. Effective early stage diagnosis of patients requires specialist skills and ODAk partners already have good links with some of the key centres in Europe including Moorfields Eye Hospital in London and San Raffaele in Milan that will be directly linked to the trials.
If you are interested in finding out more about clinical trials please go to Contact Us for more information.